SECONDREGULARSESSION
HOUSEBILLNO.1830
102NDGENERALASSEMBLY
INTRODUCEDBYREPRESENTATIVEMCMULLEN.
4258H.01I DANARADEMANMILLER,ChiefClerk
ANACT
Torepealsection191.480,RSMo,andtoenactinlieuthereofthreenewsectionsrelatingto
alternativetherapies.
BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows:
SectionA.Section191.480,RSMo,isrepealedandthreenewsectionsenactedinlieu
2thereof,tobeknownassections191.479,191.480,and192.950,toreadasfollows:
191.479.1.Asusedinthissection,theterm"bonafidephysician-patient
2relationship"meansarelationshipbetweenaphysicianandapatientinwhichthe
3physician:
4 (1)Hascompletedanassessmentofthepatient'smedicalhistoryandcurrent
5medicalcondition,includinganin-personexaminationofthepatient;
6 (2)Hasconsultedwiththepatientwithrespecttothepatient'smedical
7condition;and
8 (3)Isavailabletoprovidefollow-upcareandtreatmenttothepatient.
9 2.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof
10lawtothecontrary,anypersonwhoacquires,uses,produces,possesses,transfers,or
11administerspsilocybinfortheperson'sowntherapeuticuseshallnotbeinviolationof
12stateorlocallawandshallnotbesubjecttoacivilfine,penalty,orsanctionsolongas
13thefollowingconditionsaremet:
14 (1)Thepersonistwenty-oneyearsofageorolder;
15 (2)Thepersonsuffersfromposttraumaticstressdisorder,majordepressive
16disorder,orasubstanceusedisorderorrequiresend-of-lifecare;
17 (3)Theperson:
EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis
intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 18 (a)Hasenrolledinaclinicaltrialtostudytheuseofpsilocybintotreat
19posttraumaticstressdisorder,majordepressivedisorder,orsubstanceusedisordersor
20forend-of-lifecare;or
21 (b)Soughttoenrollinaclinicaltrialdescribedinparagraph(a)ofthis
22subdivisionbutwasdeclinedduetolackofspaceorlackofexistingclinicaltrialsfor
23whichthepersonwaseligible;
24 (4)Thepersoninformsthedepartmentofhealthandseniorservicesthatthe
25personplanstoacquire,use,produce,possess,transfer,oradministerpsilocybinin
26accordancewiththissection;
27 (5)Thepersonprovidesthedepartmentofhealthandseniorserviceswith:
28 (a)Documentationfromaphysicianwithwhomthepatienthasabonafide
29physician-patientrelationshipthatthepersonsuffersfromposttraumaticstress
30disorder,majordepressivedisorder,orasubstanceusedisorderorrequiresend-of-
31lifecare;
32 (b)Thenameofanindividualwhowillbepresentwiththepersonwhenthe
33personusespsilocybin.Suchindividualshallbe:
34 a.Licensedasaphysician;
35 b.Licensedasatherapist;or
36 c.Licensedbythefederalgovernmentoranothergovernmententityinthe
37therapeuticuseofpsilocybin;
38 (c)Theaddressofthelocationwheretheuseofpsilocybinwilltakeplace;and
39 (d)Thetimeperiod,nottoexceedtwelvemonths,duringwhichthepersonwill
40usepsilocybin;
41 (6)Thepersonensuresthatalaboratorylicensedbythestatetotestcontrolled
42substancesteststhepsilocybinthepersonintendstoingest;and
43 (7)Thepersonlimitstheuseofpsilocybintonomorethanonehundredfifty
44milligramsofpsilocybinanalyte(4-phosphoryloxy-N,N-dimethyltryptamine)during
45anytwelve-monthperiod.
46 3.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof
47lawtothecontrary:
48 (1)Anypersontwenty-oneyearsofageorolderwhoassistsanotherpersonin
49anyoftheactsallowedundersubsection2ofthissectionshallnotbeinviolationofstate
50orlocallawandshallnotbesubjecttoacivilfine,penalty,orsanction;and
51 (2)Anylaboratorylicensedbythestatetotestcontrolledsubstancesorcannabis
52thattestspsilocybinforapersonengagedinactsallowedundersubsection2ofthis
53sectionshallnotbeinviolationofstateorlocallawandshallnotbesubjecttoacivil
54fine,penalty,orsanction.
HB1830 2 55 4.Subjecttoappropriation,thedepartmentofhealthandseniorservicesshall
56providegrantstotalingtwomilliondollarsforresearchontheuseandefficacyof
57psilocybinforpersonsdescribedinsubsection2ofthissection.
58 5.Thedepartmentofhealthandseniorservicesshallprepareandsubmittothe
59governor,lieutenantgovernor,andthegeneralassemblyannualreportsonany
60informationcollectedbythedepartmentontheimplementationandoutcomesoftheuse
61ofpsilocybinasdescribedinsubsection2ofthissection.
62 6.Thedepartmentofhealthandseniorservicesshallmaintainthe
63confidentialityofanypersonallyidentifiableprotectedinformationcollectedfromany
64personswhoprovideinformationtothedepartmentundersubsection2ofthissection.
65 7.Notwithstandinganyotherprovisionoflawtothecontrary,thedepartmentof
66healthandseniorservices,anyhealthcareproviders,andanyotherpersoninvolvedin
67theactsdescribedinsubsection2ofthissectionshallnotbesubjecttocriminalorcivil
68liabilityorsanctionunderthelawsofthisstateforprovidingcaretoapersonengagedin
69actsallowedundersubsection2ofthissection,exceptincasesofgrossnegligenceor
70willfulmisconduct.Nohealthcareprovidershallbesubjecttodisciplineagainsthisor
71herprofessionallicenseforprovidingcaretoapersonengagedinactsallowedunder
72subsection2ofthissection.
73 8.Notwithstandinganyotherprovisionoflawtothecontrary,aphysicianshall
74notbesubjecttocriminalorcivilliabilityorsanctionunderthelawsofthisstatefor
75providingdocumentationthatapersonsuffersfromposttraumaticstressdisorder,
76majordepressivedisorder,orasubstanceusedisorderorrequiresend-of-lifecare,and
77nostateagencyorregulatoryboardshallrevoke,failtorenew,ortakeanyotheraction
78againstaphysician'slicenseissuedunderchapter334basedsolelyonthephysician's
79provisionofdocumentationthatapersonsuffersfromposttraumaticstressdisorder,
80majordepressivedisorder,orasubstanceusedisorderorrequiresend-of-lifecare.
81 9.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagencyor
82employeeofastateagencyshalldisclosetothefederalgovernment,anyfederal
83governmentemployee,oranyunauthorizedthirdpartythestatewidelistorany
84individualinformationofpersonswhomeettherequirementsofthissection.
191.480.1.Forpurposesofthissection,thefollowingtermsshallmean:
2 (1)"Eligiblepatient",apersonwhomeetsallofthefollowing:
3 (a)Hasaterminalconditionorillness,alife-threateningconditionorillness,ora
4severelydebilitatingconditionorillness;
5 (b)HasconsideredallothertreatmentoptionscurrentlyapprovedbytheUnited
6StatesFoodandDrugAdministrationandallrelevantclinicaltrialsconductedinthisstate;
HB1830 3 7 (c)Hasreceivedaprescriptionorrecommendationfromtheperson'sphysicianforan
8investigationaldrug,biologicalproduct,ordevice;
9 (d)Hasgivenwritteninformedconsentwhichshallbeatleastascomprehensiveas
10theconsentusedinclinicaltrialsfortheuseoftheinvestigationaldrug,biologicalproduct,or
11deviceor,ifthepatientisaminororlacksthementalcapacitytoprovideinformedconsent,a
12parentorlegalguardianhasgivenwritteninformedconsentonthepatient'sbehalf;and
13 (e)Hasdocumentationfromtheperson'sphysicianthatthepersonhasmetthe
14requirementsofthissubdivision;
15 (2)"Investigationaldrug,biologicalproduct,ordevice",adrug,biologicalproduct,or
16device,anyofwhichareusedtotreatthepatient'sterminalconditionorillness,life-
17threateningconditionorillness,orseverelydebilitatingconditionorillness,thathas
18successfullycompletedphaseoneofaclinicaltrialbuthasnotbeenapprovedforgeneraluse
19bytheUnitedStatesFoodandDrugAdministrationandremainsunderinvestigationina
20clinicaltrial[. ThetermshallnotincludeScheduleIcontrolledsubstances];
21 (3)"Life-threateningconditionorillness",adiseaseorcondition:
22 (a)Inwhichthelikelihoodofdeathishighunlessthecourseofthediseaseis
23interrupted;and
24 (b)Withpotentiallyfataloutcomes,wheretheendpointofclinicaltrialanalysis
25issurvival;
26 (4)"Severelydebilitatingconditionorillness",adiseaseorconditionthatcauses
27majorirreversiblemorbidity;
28 (5)"Terminalconditionorillness",adiseasethatwithoutlife-sustainingprocedures
29willresultindeathinthenearfutureorastateofpermanentunconsciousnessfromwhich
30recoveryisunlikely.
31 2.Amanufacturerofaninvestigationaldrug,biologicalproduct,ordevicemaymake
32availablethemanufacturer'sinvestigationaldrug,biologicalproduct,ordevicetoeligible
33patientsunderthissection.Thissectiondoesnotrequirethatamanufacturermakeavailable
34aninvestigationaldrug,biologicalproduct,ordevicetoaneligiblepatient.Amanufacturer
35may:
36 (1)Provideaninvestigationaldrug,biologicalproduct,ordevicetoaneligiblepatient
37withoutreceivingcompensation;or
38 (2)Requireaneligiblepatienttopaythecostsoforassociatedwiththemanufacture
39oftheinvestigationaldrug,biologicalproduct,ordevice.
40 3.Thissectiondoesnotrequireahealthcareinsurertoprovidecoverageforthecost
41ofanyinvestigationaldrug,biologicalproduct,ordevice.Ahealthcareinsurermayprovide
42coverageforaninvestigationaldrug,biologicalproduct,ordevice.
HB1830 4 43 4.Thissectiondoesnotrequirethedepartmentofcorrectionstoprovidecoveragefor
44thecostofanyinvestigationaldrug,biologicalproduct,ordevice.
45 5.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagencyor
46regulatoryboardshallrevoke,failtorenew,ortakeanyotheractionagainstaphysician's
47licenseissuedunderchapter334basedsolelyonthephysician'srecommendationtoan
48eligiblepatientregardingprescriptionforortreatmentwithaninvestigationaldrug,biological
49product,ordevice.Actionagainstahealthcareprovider'sMedicarecertificationbasedsolely
50onthehealthcareprovider'srecommendationthatapatienthaveaccesstoaninvestigational
51drug,biologicalproduct,ordeviceisprohibited.
52 6.Ifaprovisionofthissectionoritsapplicationtoanypersonorcircumstanceisheld
53invalid,theinvaliditydoesnotaffectotherprovisionsorapplicationsofthissectionthatcan
54begiveneffectwithouttheinvalidprovisionorapplication,andtothisendtheprovisionsof
55thissectionareseverable.
56 7.Iftheclinicaltrialisclosedduetolackofefficacyortoxicity,thedrugshallnotbe
57offered.Ifnoticeisgivenonadrug,product,ordevicetakenbyapatientoutsideofaclinical
58trial,thepharmaceuticalcompanyorpatient'sphysicianshallnotifythepatientofthe
59informationfromthesafetycommitteeoftheclinicaltrial.
60 8.Exceptinthecaseofgrossnegligenceorwillfulmisconduct,anypersonwho
61manufactures,imports,distributes,prescribes,dispenses,oradministersaninvestigational
62drugordevicetoaneligiblepatient[withaterminalillness] inaccordancewiththissection
63shallnotbeliableinanyactionunderstatelawforanyloss,damage,orinjuryarisingoutof,
64relatingto,orresultingfrom:
65 (1)Thedesign,development,clinicaltestingandinvestigation,manufacturing,
66labeling,distribution,sale,purchase,donation,dispensing,prescription,administration,or
67useofthedrugordevice;or
68 (2)Thesafetyoreffectivenessofthedrugordevice.
192.950.1.Notwithstandingtheprovisionsofchapter195or579tothecontrary,
2thedepartmentofhealthandseniorservices,incollaborationwithahospitaloperated
3byaninstitutionofhighereducationinthisstateorwithcontractresearchorganizations
4conductingtrialsapprovedbytheUnitedStatesFoodandDrugAdministration,shall
5conductastudyontheefficacyofusingalternativemedicineandtherapies,including
6theuseofpsilocybin,inthetreatmentofpatientswhosufferfromposttraumaticstress
7disorder,majordepressivedisorder,orsubstanceusedisordersorwhorequireend-of-
8lifecare.
9 2.(1)Inconductingthestudy,thedepartmentofhealthandseniorservices,in
10collaborationwiththehospitalorcontractresearchorganizationsdescribedin
11subsection1ofthissectionandsubjecttoappropriations,shall:
HB1830 5 12 (a)Performaclinicaltrialonthetherapeuticefficacyofusingpsilocybininthe
13treatmentofpatientswhosufferfromposttraumaticstressdisorder,majordepressive
14disorder,orsubstanceusedisordersorwhorequireend-of-lifecare;and
15 (b)Reviewcurrentliteratureregarding:
16 a.Thesafetyandefficacyofpsilocybininthetreatmentofpatientswhosuffer
17fromposttraumaticstressdisorder,majordepressivedisorder,orsubstanceuse
18disordersorwhorequireend-of-lifecare;and
19 b.Theaccessthatpatientshavetopsilocybinforsuchtreatment.
20 (2)Thedepartmentofhealthandseniorservicesshallprepareandsubmittothe
21governor,lieutenantgovernor,andthegeneralassemblythefollowing:
22 (a)Quarterlyreportsontheprogressofthestudy;and
23 (b)Awrittenreport,submittedoneyearfollowingthecommencementofthe
24study,whichshall:
25 a.Containtheresultsofthestudyandanyrecommendationsforlegislativeor
26regulatoryaction;and
27 b.Highlightthoseclinicalpracticesthatappeartobemostsuccessfulaswellas
28anysafetyorhealthconcerns.
29 3.Thedepartmentofhealthandseniorservicesshallmaintainthe
30confidentialityofanypersonallyidentifiableprotectedinformationcollectedduring
31theclinicaltrialunderthissection.
32 4.Notwithstandinganyotherprovisionoflawtothecontrary,thedepartmentof
33healthandseniorservices,anyhealthcareproviders,andanyotherpersoninvolvedin
34theclinicaltrialunderthissectionshallnotbesubjecttocriminalorcivilliabilityor
35sanctionunderthelawsofthisstateforparticipatinginthetrial,exceptincasesofgross
36negligenceorwillfulmisconduct.Nohealthcareprovidershallbesubjecttodiscipline
37againsthisorherprofessionallicenseforparticipationinthetrial.
38 5.Notwithstandinganyotherprovisionoflawtothecontrary,aphysicianshall
39notbesubjecttocriminalorcivilliabilityorsanctionunderthelawsofthisstatefor
40referringapatienttotheclinicaltrialunderthissection,andnostateagencyor
41regulatoryboardshallrevoke,failtorenew,ortakeanyotheractionagainsta
42physician'slicenseissuedunderchapter334basedsolelyonthephysician'sreferralofa
43patienttotheclinicaltrialunderthissection.
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HB1830 6